Madison Polymeric Engineering
Medical device manufacturer in Branford, CT.
2510(k) clearances
0PMA approvals
11recalls
510(k) clearances
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1925-2019 Class II | First Step Draco Pad, Product Number EP-4DThis product has been contaminated with Stenotrophomonas lactiubi. | 05/08/2019Terminated |
| Z-1924-2019 Class II | Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number…This product has been contaminated with Stenotrophomonas lactiubi. | 05/08/2019Terminated |
| Z-0969-2019 Class II | Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered…The product is contaminated with Pseudomonas. | 12/14/2018Terminated |
| Z-1900-2018 Class II | Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent…The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. | 03/21/2018Terminated |
| Z-1899-2018 Class II | Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible…The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. | 03/21/2018Terminated |
| Z-1898-2018 Class II | First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit…The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. | 03/21/2018Terminated |
| Z-1897-2018 Class II | First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope…The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. | 03/21/2018Terminated |
| Z-1896-2018 Class II | First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit…The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. | 03/21/2018Terminated |
| Z-1895-2018 Class II | First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit…The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. | 03/21/2018Terminated |
| Z-1182-2018 Class II | First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of…Affected lots may have exceeded its microbial limits. | 11/03/2017Terminated |
| Z-2211-2017 Class II | Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305ZProduct is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae. | 04/17/2017Terminated |